11/16/2017

2016 Fundamentals of Mohs Surgery San Diego, CA

Daniel H. Gong, MS, MSO, C-PM Management Services Officer Clinical Service/Laboratory Manager Daniel H. Gong, MS, MSO, C-PM

UC Davis Dermatology, Mohs Laboratories UC Davis Dermatopathology Service No Disclosure of Relevant Relationships with Industry

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CLIA Documentation in the Mohs Lab What is CLIA? y What is CLIA? Types of CLIA labs y Clinical Laboratoryor Improvement Amendments y CLIA Documentation in the Mohs Lab (Established in 1988 by the Federal Government) y Lab Manual- QC Program, Lab Classifications, and y CLIA Regulations: Lab Procedures 1) Establish/follow written polices and procedures y QC Monitors: Temperature, Equipment (Cryostat, Stainer, Refrigerator, Eyewash Station, Fume Hood, Autoclave, Microscope), 2) Take corrective actions, as necessary Service Reports, Reagent and Stain and Corrective Action 3) Review effectiveness of the assessments and y Proficiency Testing Requirements corrective actions taken y Preparing for a CLIA Inspection 4) Revise policies and procedures, as necessary y Guidelines for Counting Tests 5) Communication with staff on assessments y Quality Assessment Process 6) Document all assessment activities

Distribute Types of CLIA Labs Lab Procedure Manual 1) Waived – simple tests that do not require additional y The Lab Manual reflects the current practices of the quality assessment (see current list of waived tests) laboratory. http://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/Downloads/waivetbl.pdf y New procedures and all changes to the Manual must 2) Moderate Complexity – most automated tests that do be approved, signed and dated by the Laboratory not Notmeet the waiver criteria (e.g., KOH exams, fungal Director cultures, and staining procedures) 3) High Complexity – non-automated tests ( e.g., y histopathology, Mohs Surgery) The Lab Director will also review, sign, and date each Do lab manual annually

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Lab Procedure Manual 1) Quality Control Program y General Policy – QC program ensures testing/results 1) Quality Control Programs are accurate and in compliance. y Training – Employees trained in QA and QC procedures 2) Laboratory Classification y Documentation – Results of QC analyses will be documented. 3) Laboratory Procedures y Maintenance Checks – Equipment maintained according to protocols. y Corrective Actions – All corrective actions must be documented. Duplicate Temperature Monitors Equipment Monitors y Cryostator QC y Monitor Daily Room Temperature y Stainer QC y Changes in Room Temperature must be documented y Refrigerator QC

y Check humidity in the Laboratory y Eyewash Station QC y Fume Hood or Extractor QC y Warmer temperatures requires the Cryostat to work harder y Autoclave QC y Microscope QC

CryostatDistribute QC Stainer QC Not

Do Specify acceptable ranges

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Refrigerator QC Eyewash Station

Specify what you are testing

Duplicate Fume Hood or Extractor QC orAutoclave QC

MicroscopeDistribute QC Slide QC Not Do

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Service Reports Service Repair Forms

y Yearly Preventative Maintenance (PM) Reports

y Equipment Repairs

y Service Reports should specify Model/Serial #

y Follow up on any PM report recommendations

y Ask about equipment recalls Duplicate Reagent and Supplies Reagent Log

orOr Lot # The laboratory must define proper storage of reagents and specimens

All reagents should have the following on the labels: -identity, titer, concentration, storage requirements, received and open date, initials

The laboratory must maintain an inventory to track reagents using a running balance system.

Distribute Corrective Actions Corrective Action Form y Written policies and procedures for corrective action must be available and followed as necessary to maintain operations to ensure accurate and reliable test results.

y All laboratoriesNot must document all corrective actions taken Do

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2) Laboratory Classification 3) Laboratory Procedures y Waived Testing – www.cms.hhs.gov/clia Histopathology in Mohs Surgery is High Complexity y Provider Performed Microscopy (PPM) – e.g, KOH y Principle of Test preparations y Specimen Collection, Rejection, and Handling y Moderate and High Complexity Testing – Mohs Histopathology y Materials, Equipment, and Reagents Used y CLIA Certificates: Waiver, PPM Procedures, y Test Procedure – Sectioning Specimens, H and E Registration, Compliance, and Accreditation Staining of frozen sections y Application for Certification (CMS-116) y Quality Control Analyses – Daily and Random Case Reviews www.cms.hhs.gov/forms/cms116 y Results – Mohs Map and Final Histopathology Report Duplicate

Proficiency Testing/Grossing Requirements Preparing for a CLIA Inspection CLIA inspections are performed every two years for y High Complexity Labs (e.g., Mohs Lab): Proficiency moderateor or high complexity lab. testing is a way to verify your lab tests through an external source. Send your cases to a local Common Deficiencies: colleague (minimum twice a year). Incomplete written policies/procedure manuals 1) No formal quality assessment program y Grossing Educational Requirements: Bachelor’s in 2) Maintaining Equipment medical technology, CLS, Chem/Phy/Biological Science. 3) Expired Reagents Associate degree in lab science or medical laboratory education and training equivalent to associate degree: 60 4) Lack of proficiency testing semester hrs – 24 sem hrs of mlt or 24 sem hrs of science 5) Provide documents in organized manner ahead of courses (6hrs each of biology/chemistry and 12 hrs time chem/bio or medical lab technology, or any combination 6) Poor storage of reagents

Distribute Guidelines for Counting Tests Quality Assessment Process 1) Assessment Process – What does it include? For histopathology, each block is counted as one test. 2) Frequency of the Review

Laboratories that perform special stain on histology 3) Corrective Action Process slides;Not the test volume is determined by adding the number of special stains to total number specimen.

For Mohs, each stage counts as one test. Do

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Assessment Process Encompasses Frequency of Review

1) All Technical and non-technical functions 1) Establish a schedule or plan for ongoing monitoring 2) All locations/sites where testing is performed 2) The frequency of monitoring will depend on the 3) Interactions with and responsibilities to patients, problem and corrective action taken physicians, other laboratories, and non-laboratory 3) Use the deficiencies and recommendations cited areas or departments of a facility during CLIA surveys for areas to monitor Duplicate Corrective Action Process Commonor Deficiencies in CLIA Inspections 1) Identification of the problem y Clearly defined temperature ranges 2) Resolution of the problem y Acceptable temperature ranges 3) New polices that will prevent recurrence y Regular review of temperatures and noted actions 4) Communication of written polices and the action when temperature is out of range. taken to prevent future problems y QC for stains 5) Monitor corrective actions y How often are you changing your stains 6) Include personnel and staff in the review process 7) Document! Document! Document!

Distribute References Conclusion CLIA Regulations/Laws http://www.ecfr.gov/cgi-bin/text- CLIA Survey Documentation Focus: idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5

http://www.gpo.gov/fdsys/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42- 1) Procedure manual chap6A-subchapII-partF-subpart2-sec263a.pdf 2) Personnel Records (e.g., training and experience, American Academy of Dermatology Clinical Laboratory competencyNot assessment) Improvement Amendments (CLIA) for Dermatology 3) QC records (e.g., calibration records, instrument maintenance Interpretative guidelines for CLIA surveys 4) Quality Assessment Plan and Documentation https://www.cms.gov/Regulations-and- Do Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html

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Thank You

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